EMBRACE evaluates blood pressure management with RDN in patients undergoing staged percutaneous coronary intervention (PCI) for advanced coronary artery disease (CAD). The randomized, multi-center trial looks at Symplicity Spyral added to staged PCI versus staged PCI alone. Patients have uncontrolled hypertension and multi-vessel CAD. The company announced the study at ACC 2026 in New Orleans.
Symplicity Spyral delivers radiofrequency energy to nerves near the kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure. The RDN system holds approval for commercial use in more than 80 countries.
Medtronic received approval for the system in November 2023. Competitors include Recor Medical and its Paradise system, plus Boston Scientific through its acquisition of SoniVie.
According to the medtech giant, the unique study assesses clinical effectiveness with radiofrequency RDN using a composite endpoint. That endpoint includes cardiovascular death, stroke, myocardial infarction, and hospitalization for heart failure or hypertensive crisis, among others. Medtronic said investigators will assess the primary endpoint at two years, with a total follow-up extending to three years.
The investigator-initiated study funded by Medtronic will enroll 1,000 with multi-vessel disease and uncontrolled hypertension undergoing staged PCI. It takes place across 55 sites in up to 20 countries in the U.S., Europe and Asia.
Dr. Roxana Mehran, professor of medicine and director of interventional cardiovascular. research and clinical trials at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, and Dr. Felix Mahfoud, professor of cardiology at the University of Basel and Chief of Cardiology at the University Hospital Basel, lead the trial.
Commentary from Medtronic officials and study leaders
Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic, said:
“Uncontrolled hypertension is a major driver of coronary artery disease progression and recurrent ischemic events. The EMBRACE study complements our robust clinical program to benefit complex patients with high blood pressure and coronary artery disease. These patients are called out in global guidelines as needing more aggressive hypertension management. Our physician-initiated studies, including the EMBRACE study, strongly reflect the priorities of the cardiovascular clinical community.”
Jason Fontana, VP and GM of Medtronic’s Renal Denervation business, said:
“Continuing to build on the evidence base of Symplicity, we are excited to partner with Dr. Mehran and Dr. Mahfoud for the EMBRACE trial to help understand if the approach will more aggressively bend the cardiovascular (CV) risk curve in high CV risk patients.
Dr. Mehran added:
“PCI is no longer the end of the journey – it’s the beginning of a broader strategy to address residual cardiovascular risk,” said Dr. Mehran. “Uncontrolled hypertension remains a key driver of recurrent events, and EMBRACE explores a potential ‘sweet spot’ where revascularization and renal denervation can be combined to move from intervention to prevention.”
More from the company on Symplicity Spyral
Medtronic also announced new insights for its RDN system at ACC 2026.
Dr. Michael Böhm, director of the Klinik fur Innere Medizin III and and chief of cardiology at the University of the Saarland in Homburg/Saar in Germany, presented results from a pooled analysis of the SPYRAL HTN ON- and -OFF MED trials.
The analysis included 388 patients randomized to RDN and 315 to sham control. It showed that RDN patients had a significantly lower rate of hypertensive urgencies (40%) compared to sham-controlled patients through three years.
Cumulative mean hypertensive urgency incidence at three years came in at 0.21 for RDN and 0.39 for sham. RDN patients had a statistically significant lower medication burden compared to sham at three years. Medtronic estimates potential hypertensive urgency-related healthcare cost savings in the U.S. totaling approximately $380 million annually. This assumes a RDN adoption rate of 50%.
“With the insights from our SPYRAL HTN ON-MED, OFF-MED trials, we are seeing additional clinically meaningful health system benefits of Symplicity Spyral, including fewer emergent hypertensive events and lower medication burden,” said Fontana. “This underscores the value to the health care system, with reductions in emergency department admissions for hypertensive events resulting in an estimated $380 million per year in potential savings in the U.S.”
